NKTR-181 for Chronic Lower Back Pain: SUMMIT-07 Results

Patients are often diagnosed with SpA on the basis of inflammatory low back pain.
Patients are often diagnosed with SpA on the basis of inflammatory low back pain.
The phase 3 SUMMIT-07 trial assessed the safety, efficacy, and tolerability of a new mu-opioid receptor agonist analgesic in adults with moderate to severe chronic lower back pain.
The following article is part of The Clinical Advisor’s coverage from the 2018 American Association of Nurse Practitioners’ annual meeting in Denver. Our staff will be reporting live on original research, case studies, and professional outreach and advocacy news from leading NPs in various therapeutic areas. Check back for ongoing updates from AANP 2018. 

DENVER – For patients with moderate to severe chronic low back pain, NKTR-181 100 to 400 mg twice daily significantly reduces pain with a low rate of adverse events, according to results presented at the American Association of Nurse Practitioners 2018 conference.

NKTR-181 is a new, full mu-opioid receptor agonist that has a slower rate of entry into the central nervous system compared with standard opioids.

SUMMIT-07 (ClinicalTrials.gov Identifier: NCT02362672) included participants with moderate to severe back pain who were opioid naive (n=610). Participants were randomly assigned to receive NKTR-181 (n=309) or placebo (n=301). The primary end point was change in weekly pain score from baseline to week 12, and secondary end points were percentages of study completers with week 12 pain scores reduced ≥30% and ≥50%, as well as adverse events.

At week 12, the NKTR-181 group had a least-squares mean change in weekly pain scores from baseline of +0.92 compared with +1.46 for those receiving placebo (P =.0019), indicating a significantly greater analgesic effect with treatment.

In the NKTR-181 group, 71.2% of participants had pain reductions of ≥30% at week 12, and 51.5% had ≥50% reductions compared with 57.1% and 37.9%, respectively, for those receiving placebo (P ≤.001).

Adverse events were reported by 54.4% of participants in the NKTR-181 group and 49.8% in the placebo group. Few instances of central nervous system-related adverse events commonly associated with opioids were reported in the treatment group (<3%).

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Disclosure:  The study was sponsored by Nektar Therapeutics.

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Markman J, Gudin J, Rauck R, et al. Efficacy, safety, and tolerability of NKTR-181 in patients with moderate to severe chronic low-back pain: a phase 3 study. Presented at the American Association of Nurse Practitioners 2018 National Conference. June 26-July 1, 2018; Denver, CO. Poster 11.

This article originally appeared on Clinical Advisor